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January 27, 2011

Amicus Briefs in AMP v. USPTO: AARP

With briefing in the Association of Molecular Pathology v. U.S. Patent and Trademark Office ("Myriad") case now complete, Patent Docs has begun reviewing the 29 amicus briefs that were filed with the Court of Appeals. Of the 29 amicus briefs, fifteen were filed in support of Defendants-Appellants and/or reversal, twelve were filed in support of Plaintiffs-Appellees and/or affirmance, and two remain to be determined (Patent Docs has not yet obtained copies of these briefs). To date, Patent Docs has provided summaries for nine of the fifteen of the briefs filed in support of Defendants-Appellants and/or reversal (see "AMP v. USPTO -- Briefing Update II"). Today, we review the amicus brief submitted by the AARP.

Writing in support of Plaintiffs-Appellees and arguing for affirmance, the AARP "urg[es] the Court to find that the [BRCA] patents are invalid." According to the AARP, the Federal Circuit should find the patents to be invalid because "[p]atents such as those present in this case prohibit diagnosis and treatment based on second medical opinions and discourage full medical testing," and patents "also significantly elevate the cost of genetic testing." The AARP spends a little more than one page of its 22-page brief explaining why human genes and DNA molecules are not patent eligible under 35 U.S.C. § 101. The remainder of the AARP brief focuses on public health considerations that demand a finding of invalidity and a discussion of how gene patents limit the accessibility of competitively priced genetic testing.

With respect to the § 101 issue, the AARP argues that "DNA molecules and human genes are natural phenomena that when discovered are not the kind of 'discovery' that Section 101 was designed to protect." Citing American Wood-Paper Co. v. Fiber Disintegrating Co., 90 U.S. (23 Wall.) 566 (1874), the AARP states that in that case:

[T]he Court found that merely removing pulp from straw, wood, or other natural sources did not make it a patentable new composition of matter: "A process to obtain it [an extract] from a subject from which it has never been taken may be the creature of invention, but the thing itself when obtained cannot be called a new manufacture."

The AARP argues that "[s]imilarly, isolating a gene from the human body does not then make the gene itself, patentable." From this, the AARP concludes that "human genes and DNA molecules, regardless of whether they are isolated or not, are natural phenomena and therefore are not patent eligible under 35 U.S.C. §101" (emphasis added).

Noting that Myriad, in its opening brief, "fails to discuss potential patient harm if the [BRCA] patents are upheld," the AARP turns to public health considerations that "demand that the patents in question be denied." In particular, the AARP argues that "[i]n this case the public interest demands that the patents in question be denied since many individuals will be harmed if the patent is upheld because genetic testing will be denied to them either due to cost or unavailability of a second opinion." Pointing to the results of "a study [that] was conducted of 300 individuals who had negative test results from Myriad's BRAC analysis but came from families in the United States, each of which included four or more members with breast or ovarian cancer," the AARP brief notes that "[u]sing multiple methods of genetic testing, unlike BRAC analysis, the study found that 35 of the 300, or in other words 12% of the individuals, carried previously undetected BRCA1 or BRCA2 genetic mutations." Because "it is extremely important that those who undergo BRCA genetic testing receive accurate and thorough testing and results," the AARP contends that "individuals seeking any type of genetic testing should have the option of securing a second opinion which can have life altering results." Given the federal government's limited oversight over genetic tests, the AARP argues that it is critical that patients have the option of a second opinion.

The AARP brief next addresses the ways in which gene patents limit the accessibility of competitively priced genetic testing. Citing a Department of Health and Human Services report, the AARP notes that "[w]hile advances in genetics and genomics are driving the development of new genetic tests and services, 'problems with coverage and reimbursement are limiting their accessibility and integration into the health care system.'" The AARP also points to the "significant numbers of Americans (50.7 million) who are still uninsured," and the fact that "[t]he cost of health care frequently determines whether or not people receive health care." The brief also notes that while "Medicare is the largest provider of health insurance in the United States," "its current coverage policy of genetic testing is limited." Stating that "Medicare generally precludes coverage of genetic testing to those people who have not yet been diagnosed with cancer," the AARP argues that "[r]equiring that Medicare recipients wait until they actually have contracted cancer reduces one of the most significant benefits of the testing to those BRAC carriers who have not yet contracted cancer but may do so in the future." The brief concludes that:

Given the limited coverage of genetic testing for Medicare and Medicaid patients many patients must pay for genetic testing out of their own pockets. Rejecting the patents in this case and allowing more laboratories to do the tests will result in lower prices for the tests and greater patient access.